BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    ONE STICK Y EXTENSION SET AND VOLUMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLINICAL SPECTROPHOTOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 10, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·October 29, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 2015

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014